Is Treatment With FMS Tesla Chair Equal to Physiotherapy in First and Second-degree Urinary Incontinence?

Kantonsspital Winterthur KSW

Status

Not yet enrolling

Conditions

Urinary Incontinence

Treatments

Procedure: Physiotherapy

Device: Tesla-Chair

Study type

Interventional

Funder types

Other

Identifiers

NCT07265700

Tesla-UI

Details and patient eligibility

About

100 patients with mild to moderate urinary incontinence will be randomly divided into two groups. One half will receive functional magnetic stimulation with the Tesla Chair for three months, while the other half will be treated with pelvic floor physiotherapy for the same period. After three and six months, a comparison will be made to determine which patient groups experience an improvement in urinary incontinence and how their muscle strength improves.

Full description

Urinary incontinence is a debilitating condition that significantly impacts patients' quality of life, contributing to anxiety, depression, and social withdrawal. The severity of stress urinary incontinence (SUI) is directly correlated with increased physical and psychological burden. Although lifestyle modifications can offer moderate symptom relief, the current gold-standard first-line treatment is pelvic floor physiotherapy, with surgical intervention reserved for refractory cases.

Functional magnetic stimulation (FMS) has demonstrated positive effects in patients with urinary incontinence, including improvements in urodynamic parameters. However, limited research has directly compared the efficacy of FMS as a first-line therapy with standard pelvic floor physiotherapy. Addressing this gap is essential for informing clinical practice and expanding evidence-based therapeutic options. The efficacy of pelvic floor physiotherapy is commonly evaluated using the Oxford Scale, which provides an objective measure of pelvic floor muscle contraction strength. Additionally, patient-reported outcomes are assessed using validated instruments, including the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF UI) and the German Pelvic Floor Questionnaire (Deutscher Beckenbodenfragebogen), capturing symptom severity and quality of life. Together, these endpoints-objective assessments and patient-reported outcomes-offer a comprehensive evaluation of treatment effectiveness.

Enrollment

100 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥ 18 years
Urinary incontinence of first or second degree
Written informed consent
German speaking (Study information and IC available only in German)

Exclusion criteria

Pregnancy or desire to become pregnant
Urinary incontinence of third degree
Third or fourth degree pelvic organ prolapses
no noticeable voluntary muscle activity according to Oxford = O/5
Genital infections
Malignant tumors
Severe neurological diseases
Cardiac arrhythmia
Active internal medical devices e.g. cardiac pacemakers, medication pumps etc.
Ferromagnetic implants at or near the site of stimulation
Recent surgery at the site of stimulation
Thrombosis or thrombophlebitis
Epilepsy or suspected epilepsy
Acute stages of kidney stones
Gastrointestinal and internal disease at the site of stimulation
Known or suspected non-compliance, drug or alcohol abuse
Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject
Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation
Previous enrolment into the current investigation
Enrolment of the Sponsor or PI, their family members, employees and other dependent persons